跳至主要内容
临床试验/CTRI/2023/09/058140
CTRI/2023/09/058140尚未招募不适用

Comparing The Efficacy of Ultrasound Guided Bilateral-transverses Thoracic Plane Block Versus Bilateral Thoracic Paravertebral Block in Elective Pediatric Cardiac Surgery Patients - A Randomised Study

Dr Padma S1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
assess & compare hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial blood pressure) and peri operative opoid requirement to incision and sternotomy

研究概览

简要总结

Median sternotomy in cardiac surgery is very painful. Hence need of regional block which can spare opoid use specially in pediatric age group. Hence we are comparing two truncal blocks and its post operative opoid requirements along with intra op hemodynamic changes, pain score in the ICU stay. Here we are comparing Ultrasound guided Paravertebral block and Transversus thoracic plane block containing Bupivacaine and fentanyl. The results will be analysed and discussed.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.All patients Aged 1year to 12 years of age.
  • 2.ASA grade II.
  • 3.All pediatric patients scheduled for elective cardiac surgery via median sternotomy.
  • 4.Patients planned for early extubation.

排除标准

  • 1.Parental refusal for the study.
  • 2.Patients with pectus excavatum and carinatum.
  • 3.Patients with documented local anesthetic and opioid allergy.
  • 4.Patients scheduled for emergency surgeries and nonmedian sternotomy procedures.
  • 5.Patients preoperatively intubated 6.Patients planned postoperative ventilation greater than 12 hours 7.Patients planned for complex cardiac surgeries( Risk Adjustment for Congenital Heart Surgery (RACHS-1) score >3.

结局指标

主要结局

assess & compare hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial blood pressure) and peri operative opoid requirement to incision and sternotomy

时间窗: Baseline, after induction, after block, 10th , 20th and 30th min after block, after incision, after sternotomy, post Cardio Pulmonary Bypass and last after skin closure.

次要结局

  • Comparing time taken for extubation, pain assessment, length of ICU stay(Hourly for 24 hours)

研究者

发起方
Dr Padma S
申办方类型
Other [self]

研究点 (1)

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